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Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery

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ClinicalTrials.gov Identifier: NCT01701102
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : March 10, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
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Brief Summary:
Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic (a medication that, when injected around nerves, blocks nerve conduction, resulting in numbness and weakness) used in the spine, but too low a dose can result in an incomplete block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.

Condition or disease Intervention/treatment Phase
Arthroscopic Knee Surgery Procedure: Mepivacaine (24 mg) plus fentanyl Procedure: Mepivacaine (27 mg) plus fentanyl Procedure: Mepivacaine (30 mg) plus fentanyl Procedure: Mepivacaine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Optimal Dose of Spinal Mepivacaine Combined With Fentanyl For Knee Arthroscopy
Study Start Date : December 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Mepivacaine 37.5 mg Procedure: Mepivacaine
Mepivacaine 37.5 mg
Active Comparator: Mepivacaine 30 mg plus fentanyl 10 µg Procedure: Mepivacaine (30 mg) plus fentanyl
Mepivacaine (30 mg) and fentanyl (10 µg)
Active Comparator: Mepivacaine 27 mg plus fentanyl 10 µg Procedure: Mepivacaine (27 mg) plus fentanyl
Mepivacaine (27 mg) and fentanyl (10 µg)
Active Comparator: Mepivacaine 24 mg plus fentanyl 10 µg Procedure: Mepivacaine (24 mg) plus fentanyl
Mepivacaine (24 mg) and fentanyl (10 µg)


Outcome Measures
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Primary Outcome Measures :
  1. Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU) [ Time Frame: Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours. ]
    The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects aged 18-60
  • Patients scheduled for "simple" knee arthroscopies, including meniscectomy, debridement, and plica.

Exclusion Criteria:

  • Subjects aged <18 or >60
  • Subjects greater than 190 cm in height
  • Patients scheduled for ligament reconstruction or surgery involving bone
  • Daily use of narcotics for greater than one week pre-op
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701102


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
More Information
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01701102    
Other Study ID Numbers: 11140
First Posted: October 4, 2012    Key Record Dates
Results First Posted: March 10, 2016
Last Update Posted: April 5, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Fentanyl
Mepivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local